FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
2041–2064 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200,...
K072783 · JKA
Smiths Medical Asd, Inc.
Chemistry · 60d
Cleared Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P...
K072115 · CGX
Horiba Abx
Chemistry · 121d
Cleared Nov 26, 2007
PRIMUS A1CARE ASSAY
K062658 · LCP
Primus Corp.
Chemistry · 446d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4...
K071224 · CDD
Dade Behring, Inc.
Chemistry · 195d
Cleared Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
K063852 · JKA
Home Access Health Corp.
Chemistry · 316d
Cleared Nov 06, 2007
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · NDY
Gentian AS
Chemistry · 172d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 209d
Cleared Oct 26, 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222,...
K071493 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
K070484 · NGA
Quantrx Biomedical Corporation
Chemistry · 244d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Oct 19, 2007
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
K062932 · JKA
Ahlstrom Mount Holly Springs, LLC
Chemistry · 386d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1...
K072435 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
K071593 · CHH
Polymer Technology Systems, Inc.
Chemistry · 126d
Cleared Oct 15, 2007
AMNISCREEN HOME DETECTION LINER KIT
K071100 · CEN
Common Sense , Ltd.
Chemistry · 179d
Cleared Oct 12, 2007
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · CDQ
Horiba Abx
Chemistry · 269d
Cleared Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
K063295 · LJX
ACON Laboratories, Inc.
Chemistry · 345d
Cleared Oct 09, 2007
DCA VANTAGE, MODEL 5075
K071466 · LCP
Siemens Medical Solutions Diagnostics
Chemistry · 133d
Cleared Oct 05, 2007
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
K072543 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Oct 05, 2007
ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
K072204 · JIX
Siemens Medical Solutions Diagnostics
Chemistry · 58d
Cleared Oct 05, 2007
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
K071340 · KHS
Thermofisher Scientific OY
Chemistry · 144d
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788 · NHG
Roche Diagnostics
Chemistry · 197d
Cleared Oct 03, 2007
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E
K072039 · NBW
Taidoc Technology Corporation
Chemistry · 70d
Cleared Oct 03, 2007
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
K071580 · CIT
Thermofisher Scientific OY
Chemistry · 117d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480 · MRG
DiaSorin, Inc.
Chemistry · 125d